Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients (I-Nursing)
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|ClinicalTrials.gov Identifier: NCT03176329|
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : August 15, 2018
Nursing is essential in critically ill patients care but with high risk of hypoxia, especially during mobilization. Full closed-loop control ventilation is well established for her safety in unselected ventilated critical care patients with different lung conditions compared to conventional ventilation.
The aim of this study is to assess the ability of a full closed-loop control ventilation (Intellivent-ASV, TM) to reduce hypoxia during mobilization period in unselected ventilated patients.
|Condition or disease||Intervention/treatment||Phase|
|Critical Ill Patients Ventilated Patients||Other: Nursing 1 : INTELLIVENT-ASV Other: Nursing 2 : INTELLIVENT-ASV Other: Nursing 1 : Conventional mode Other: Nursing 2 : Conventional mode||Not Applicable|
Prospective randomized cross over study including all consecutive ventilated patient with predicted duration of ventilation > 48 hours, inspired oxygen fraction < 60% and without neuromuscular blocking agent.
Patient were randomized to be ventilated with full closed-loop control or conventional ventilation 30 minutes before the first nursing period after inclusion. The ventilator was switched in the other mode (conventional or full closed-loop respectively), 30 minutes before the following nursing period. Between this two consecutive nursing periods, ventilation mode is choosed by the attending physician.
The primary outcome was the oxygenation measured by pulse oxymetry during the nursing periods.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||267 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Prospective randomized crossover study|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients : a Prospective Randomized Crossover Study|
|Actual Study Start Date :||September 19, 2016|
|Actual Primary Completion Date :||July 31, 2018|
|Actual Study Completion Date :||July 31, 2018|
INTELLIVENT-ASV / Conventional mode
Full closed-loop ventilation control (INTELLIVENT-ASV) is set 30 minutes before Nursing 1 after randomization. Ventilator is switch to conventional ventilation 30 minutes before Nursing 2
Other: Nursing 1 : INTELLIVENT-ASV
Other: Nursing 2 : Conventional mode
Conventional mode / INTELLIVENT-ASV
Conventional ventilation control is set 30 minutes before Nursing 1 after randomization. Ventilator is switch to full closed-loop ventilation (INTELLIVENT-ASV) 30 minutes before Nursing 2.
Other: Nursing 2 : INTELLIVENT-ASV
Other: Nursing 1 : Conventional mode
- Time spent with SpO2 values > 90 and < 95% [ Time Frame: 1 day ]Pulse oxymetry monitoring
- Time spent with SpO2 values < or = 90% [ Time Frame: 1 day ]Pulse oxymetry monitoring
- Time spent with SpO2 values > or = 95% [ Time Frame: 1 day ]Pulse oxymetry monitoring
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176329
|Centre Hospitalier de Melun|
|Melun, Ile De France, France, 77000|
|Principal Investigator:||Jonathan Chelly, MD||Mixed, ICU, Centre Hospitalier de Melun|